Clinical Trial: Study on the Impact of Stem Cell Donation and Bone Marrow Harvesting on Unrelated Donors

Study Status: Completed
Recruit Status: Completed
Study Type: Observational




Official Title: Multi Centre Controlled Study on the Impact of Stem Cell Donation Either After Mobilisation With Granulocyte Colony Stimulating Factor or Bone Marrow Harvest on Unrelated Bone Marrow Donors.

Brief Summary:

Granulocyte Colony Stimulating Factor (GCSF) is used extensively as a means of mobilising donor peripheral blood stem cells as an alternative to bone marrow harvesting for the purpose of recipient stem cell transplantation. The principal objective of the research is to study any longterm genetic effects of GCSF in the peripheral blood white cells of unrelated blood stem cell donors.

The study subjects will be Retrospective and Prospective voluntary unrelated donors on the Anthony Nolan Bone Marrow Registry being harvested at the Royal Free Hospital and University College Hospital, London and British Bone Marrow Registry donors harvested at the Royal Free Hospital and BUPA Glen Vale in Bristol.

All participants in the Prospective Arm will be asked to donate one 5−10ml sample of blood at study entry prior to stem cell donation and further samples at 120 and 360 days post donation. Those found to carry aneuploid cell clones at these time points will be asked for a further 5−10ml blood sample at least twice − at the end of 24 months and 36 months respectively. The Retrospective and Positive Control group will be asked to supply one 5−10ml sample of blood.